Human Papillomavirus Test Complements Pap Test

A new human papillomavirus (HPV) diagnostic test has been launched for the most important HPV genotypes, including those present in recently approved prophylactic vaccines. The test will provide an important complement to Pap smear testing and current DNA-based HPV screening tests.

HPV infection is strongly related to the development of cervical cancer. At present, women are screened preventively for signs of the disease or its onset by Pap smear testing. While the virus can occur in a variety of different related types, it has been demonstrated that genotypes 16 and 18 account for approximately 70% of cervical cancers. In addition, genotypes 6 and 11 are found in approximately 90% of genital warts.

The Inno-line probe assays (LiPA) developed by Innogenetics (Gent, Belgium) will help select individuals eligible for preventive HPV vaccination. Formal CE-marking of the test is expected before the end of October 2006.

The new diagnostic test was presented at the 23rd International Papillomavirus Congress and Clinical Workshop in September 2006, in Prague (Czech Republic). The launch of this genotyping test is particularly timed to coincide with the recent approval by European and U.S. regulatory authorities of new prophylactic HPV vaccines. These vaccines have shown convincing results in recent clinical trials. Innogenetics intends to enter this new area of infectious disease testing, complementing its established lines of diagnostic tests for hepatitis C, hepatitis B, AIDS, and tuberculosis.

Commenting on the new test, Frank Morich, CEO of Innogenetics, said, "Innogenetics has entered an exciting and important new area of infectious diseases, and initially foresees becoming a European leader in HPV genotyping. Aside from routine testing by clinical laboratories, pharmaceutical companies and institutions involved in HPV vaccine trials will be particularly interested in using our test for patient selection and follow-up monitoring as well. We expect our HPV genotyping test to fill a growing medical need as well as to further strengthen our diagnostics business.”



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